8-K: Athira Pharma Announces Second Quarter 2024 Financial Results and Provides Pipeline Update

Athira Pharma reported its second quarter 2024 financial results, highlighted by the upcoming topline data release from its Phase 2/3 LIFT-AD clinical trial in September 2024 and progress in its other clinical programs.

Summary

• Athira Pharma released its financial results for the second quarter of 2024, ending June 30th.
• The company is anticipating topline data from the Phase 2/3 LIFT-AD clinical trial for fosgonimeton by the end of the third quarter of 2024, with a presentation of the full dataset at CTAD in October 2024.
• The LIFT-AD study has completed dosing of all patients, with approximately 315 mild-to-moderate Alzheimer's disease patients participating.
• Athira is also conducting a Phase 1 clinical trial for ATH-1105, with the first cohort of healthy volunteers completed in June 2024 and trial completion expected by year-end 2024.
• The company's cash, cash equivalents, and investments totaled $91.8 million as of June 30, 2024, down from $147.4 million at the end of 2023.
• Net cash used in operations was $48.1 million for the first six months of 2024, compared to $50.5 million for the same period in 2023.
• Research and development expenses were $22.2 million for the quarter, slightly up from $21.6 million in the same quarter of 2023.
• General and administrative expenses decreased to $5.9 million from $10.0 million in the same quarter of 2023.
• The net loss for the quarter was $26.9 million, or $0.70 per share, compared to a net loss of $29.6 million, or $0.78 per share, for the same quarter last year.

Sentiment

Score: 6

Explanation: The sentiment is moderately positive due to the progress in clinical trials and the upcoming data release, but tempered by the ongoing losses and cash burn. The high OLEX enrollment is a positive sign.

Positives

• The company is nearing the release of topline data for its key LIFT-AD trial, which could be a significant catalyst.
• High enrollment rate in the OLEX trial suggests strong patient interest and potential for long-term data.
• The Phase 1 trial for ATH-1105 is progressing as planned, with the first cohort completed.
• General and administrative expenses have decreased significantly year-over-year.
• The net loss per share has improved compared to the same quarter last year.

Negatives

• The company's cash position has decreased from $147.4 million at the end of 2023 to $91.8 million as of June 30, 2024.
• Net cash used in operations was $48.1 million for the first six months of 2024.
• The company continues to operate at a loss, with a net loss of $26.9 million for the quarter.

Risks

• The topline data from the LIFT-AD trial may not be positive, which could negatively impact the company's prospects.
• The company's cash burn rate is significant, and it may need to raise additional capital in the future.
• Clinical trials are subject to various risks, including delays, regulatory hurdles, and unexpected results.
• The company faces competition from other companies developing treatments for neurodegenerative diseases.

Future Outlook

The company anticipates the release of topline data from the LIFT-AD trial by the end of the third quarter of 2024 and plans to present the full dataset at the CTAD conference in October 2024. They also expect to complete the Phase 1 trial for ATH-1105 by year-end 2024.

Management Comments

• We are excited to be fast approaching the topline data readout from our Phase 2/3 LIFT-AD clinical trial by the end of the third quarter, as we believe it will further support fosgonimeton's potential as a first-in-class therapy for mild-to-moderate Alzheimers disease patients, said Mark Litton, Ph.D., President and Chief Executive Officer of Athira.
• We were delighted to present preclinical data at the recent Alzheimers Association International Conference that showed fosgonimeton attenuated amyloid--induced autophagic impairments in primary cortical neurons, which may have important implications regarding the mitigation of pTau pathology and neurodegeneration observed in our preclinical models.

Industry Context

This announcement is relevant to the broader pharmaceutical industry focused on developing treatments for neurodegenerative diseases, particularly Alzheimer's and ALS. The results of the LIFT-AD trial are highly anticipated and could impact the competitive landscape for Alzheimer's treatments. The progress of ATH-1105 is also significant in the context of ALS research.

Comparison to Industry Standards

• Athira's focus on small molecule drugs targeting the HGF system is a unique approach compared to some competitors who are focused on monoclonal antibodies.
• The high enrollment rate in the OLEX trial is notable, as patient retention in long-term studies for neurodegenerative diseases can be challenging.
• The company's cash burn rate is consistent with other clinical-stage biotech companies, but the need for future capital raises is a common risk.
• The company's net loss is typical for a company at this stage of development, but the market will be closely watching the results of the LIFT-AD trial to determine the company's future prospects.
• Competitors in the Alzheimer's space include companies like Biogen and Eisai with their drug Leqembi, and Eli Lilly with Donanemab, both monoclonal antibodies targeting amyloid plaques. Athira's fosgonimeton is a different approach, targeting the HGF system.

Stakeholder Impact

• Shareholders will be closely watching the results of the LIFT-AD trial, which could significantly impact the stock price.
• Employees are likely focused on the progress of the clinical trials and the company's financial stability.
• Patients and their families are hopeful for positive results from the clinical trials, which could lead to new treatment options.
• Creditors and suppliers will be monitoring the company's cash position and financial performance.

Next Steps

• Release of topline data from the LIFT-AD clinical trial by the end of the third quarter of 2024.
• Presentation of the full LIFT-AD dataset at the CTAD conference in October 2024.
• Completion of the Phase 1 clinical trial for ATH-1105 by year-end 2024.

Key Dates

Keywords

Alzheimer's disease, fosgonimeton, ATH-1105, clinical trial, neurodegenerative diseases, biopharmaceutical, LIFT-AD, amyotrophic lateral sclerosis, ALS, HGF system